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NCT Number: NCT06367751

Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT)

The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel.

Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091).

Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical Oncology, University Hospital Basel

Basel, 4031, Switzerland

About this study

Liquid biopsies, in particular the analysis of circulating tumor DNA (ctDNA), have emerged as a promising tool for detecting and monitoring cancer. Measuring ctDNA in patients with solid malignancies may help to identify targetable alterations, measure disease burden, identify early mutations of resistance, tailor and deescalate cancer treatment, and predict patient prognosis. Although the adoption and application of ctDNA measurements for patients with solid tumors in routine clinical care is increasing, evidence supporting the integration of ctDNA into current practice is limited, especially for patients with advanced cancers.

This is a trial using routinely collected health care data from an ongoing registry (AO_2023-00091) in cancer patients with advanced solid malignancies receiving first line systemic anticancer treatment for advanced disease.

This trial will assess the feasibility and implementation of routine measurement of ctDNA and its association with clinical outcomes, including quality of life and survival. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent.

Results from ctDNA analyses will be discussed at the molecular tumor board, an established regular interdisciplinary meeting at the University Hospital Basel (part of routine care) to discuss patients with complex findings from tumor sequencing analyses. Treatment changes occurring during the trial duration will be at the discretion of treating physician and according to patient's preference as is routine standard of care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a proven solid malignant disease, i.e. with solid malignant tumors where no primary surgical resection is planned OR solid malignant tumors that are locally advanced and inoperable OR solid tumors that are metastatic
  • No prior treatment for advanced/metastatic disease
  • Indication for medical anti-cancer treatment (including combined chemoradiotherapy) as judged by the treating physician
  • Patient age 18 years and older
  • General research consent of the University Hospital Basel

Exclusion criteria

● Patients with primary brain tumors

Treatment and study plan

ctDNA measurement

Diagnostic Test

Blood samples are collected as part of standard of care and ctDNA measurements will be performed on these samples.

Primary outcomes

  1. Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment

    Time frame: 1 time assessment at baseline

    Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment. Calculated as the number of patients with detectable ctDNA over the total number of patients included, expressed as a percentage.

  2. Patients in whom actionable alterations were identified in ctDNA analysis

    Time frame: baseline, between month 2 and 3, between month 5 and 6, clinical event

    Patients in whom actionable alterations were identified in ctDNA analysis. Calculated as the number of patients with actionable alterations over the total number of patients included, expressed as a percentage.

    Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.

  3. Turn-around time of ctDNA analysis

    Time frame: baseline, between month 2 and 3, between month 5 and 6, clinical event

    Time from ctDNA request until issuing the first report. Expressed as hours.

    Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.

  4. ctDNA kinetics

    Time frame: up to 24 months

    Change in allelic frequency over time including relative changes from baseline.

Secondary outcomes

  1. Number of ctDNA testing results that were successfully made available to the molecular tumor board

    Time frame: up to 24 months

    Number of ctDNA testing results that were successfully made available to the molecular tumor board.

  2. Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential

    Time frame: up to 24 months

    Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential

  3. Quality of life and physical function

    Time frame: month 3, month 6, month 12

    Global quality of life and physical function as measured by EORTC QLQ C30 and C15 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire). Calculation of the scores follows the validated formulas as issued by the EORTC. Scores range from 0% to 100% for all domains with higher values representing better outcome.

  4. Overall survival

    Time frame: up to 24 months

    Overall survival.

  5. Survival rate 6 months

    Time frame: Month 6

    Survival rate 6 months.

  6. Survival rate 12 months

    Time frame: Month 12

    Survival rate 12 months.

  7. Time to next treatment line

    Time frame: up to 24 months

    Time to next treatment line, expressed in days.

  8. Unplanned hospital admissions and emergency room visits

    Time frame: up to 24 months

    Number and proportion of unplanned hospital admissions and emergency room visits.

  9. Progression free survival

    Time frame: up to 24 months

    Progression free survival as determined by routine imaging (e.g. CT scan, MRI), tumor marker (e.g. PSA). Defined as time from date of informed consent until disease progression or death, whatever occurs first.

  10. Number of ctDNA analyses with a valid result

    Time frame: up to 24 months

    Number of ctDNA analyses with a valid result - that is all ctDNA analyses conducted without any observed technical errors.

Other outcomes

  1. Patients being referred and recruited to a different interventional clinical trial

    Time frame: up to 24 months

    Number and proportion of patients being referred and recruited to a different interventional clinical trial.

  2. Tissue biopsies per patient

    Time frame: up to 24 months

    Number of (solid) tissue biopsies per patient and proportion of patients receiving a biopsy.

  3. Imaging per patient

    Time frame: up to 24 months

    Number of imaging per patient (CT, PET/CT or MRI).

  4. Blood products per patient

    Time frame: up to 24 months

    Number of blood products per patient.

  5. Cumulative doses of cancer drug treatments administered

    Time frame: up to 24 months

    Cumulative doses of cancer drug treatments administered.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Research Center for Clinical Neuroimmunology and Neuroscience Basel

Registry information

Acronym: LIQPLAT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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